Quick answers
- What is Zenatane?
- Zenatane is a brand name of Isotretinoin, a prescription medicine. The FDA NDC Directory lists 8 Zenatane products in 4 strengths and forms.
- Who makes Zenatane?
- Dr Reddys Labs Ltd holds the FDA application for Zenatane (ANDA202099, approved March 25, 2013). 1 other company (repackagers or distributors) also list Zenatane products.
- Is there a generic or store brand of Zenatane?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Zenatane product, 4 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Zenatane?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 4 Zenatane strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Zenatane been recalled?
- FDA enforcement reports list 8 recalls of Zenatane products; the newest started May 22, 2017. A recall usually concerns specific lots, not every product.
What Zenatane is
Each Zenatane product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Isotretinoin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| isotretinoin 10 mg capsule, gelatin coated (oral) | Zenatane | 1 product, 1 company | DailyMed |
| isotretinoin 20 mg capsule, gelatin coated (oral) | Zenatane | 1 product, 1 company | DailyMed |
| isotretinoin 30 mg capsule, gelatin coated (oral) | Zenatane | 1 product, 1 company | DailyMed |
| isotretinoin 40 mg capsule, gelatin coated (oral) | Zenatane | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Isotretinoin →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA202099 | Dr Reddys Labs Ltd | March 25, 2013 | 8 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| isotretinoin 10 mg capsule, gelatin coated | Generic: Zenatane | $1.96 per capsule Generic of the same strength and form: $1.96 per capsule |
| isotretinoin 20 mg capsule, gelatin coated | Generic: Zenatane | $1.93 per capsule Generic of the same strength and form: $1.93 per capsule |
| isotretinoin 30 mg capsule, gelatin coated | Generic: Zenatane | $2.01 per capsule Generic of the same strength and form: $2.01 per capsule |
| isotretinoin 40 mg capsule, gelatin coated | Generic: Zenatane | $2.19 per capsule Generic of the same strength and form: $2.19 per capsule |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Zenatane
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Zenatane products.
- BluePoint Laboratories4 products
- Dr. Reddy's Laboratories Limited4 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 22, 2017 · Class II · Terminated · D-0883-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
-
May 22, 2017 · Class II · Terminated · D-0885-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
-
May 22, 2017 · Class II · Terminated · D-0884-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
-
May 22, 2017 · Class II · Terminated · D-0886-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
-
February 15, 2017 · Class III · Terminated · D-0507-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupa — Dr. Reddy's Laboratories, Inc.
-
February 15, 2017 · Class III · Terminated · D-0509-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupa — Dr. Reddy's Laboratories, Inc.
-
February 15, 2017 · Class III · Terminated · D-0506-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachup — Dr. Reddy's Laboratories, Inc.
-
August 29, 2016 · Class III · Terminated · D-0098-2017
Failed Dissolution Specifications
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 5 — Dr. Reddy's Laboratories, Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.